To begin with, What is Moderna?
Moderna, Inc. is an US based biotechnology firm that has come to rescue during the global COVID-19 pandemic. The company is focused on creating a new generation of transformative medicines based on messenger RNA or mRNA. mRNA is used by every cell in the body to provide real-time instructions to make the proteins necessary to drive all aspects of biology. The company has built a technology platform on the same mRNA to facilitate drug discovery and development using mRNA. In simple words, synthetic mRNA is injected into the living cells of patients as a drug.
Role of Moderna in global COVID-19 pandemic
In the global COVID-19 pandemic, Moderna is the only company that has successfully done laboratory trials and progressed towards human trials. The entry of Moderna into the global COVID-19 situation goes back to January 2020. COVID-19 had just started to spread its wings. WHO had confirmed a virus outbreak by publishing the news of a handful of pneumonia cases in Wuhan district of China. Around this time, Moderna entered into the COVID-19 global scene.
January
- 11th January: China shares the genetic sequence of COVID-19 to the public
- 13th January: first positive case of COVID-19 outside of China is reported in Thailand
- On the same day, Moderna finalizes the sequence of mRNA-1273 as a possible treatment against COVID-19
- Coalition for Epidemic Preparedness Innovations (CEPI) by Bill Gates foundation funds first clinical manufacture
February
- Moderna produces first clinical batch in just 25 days
- After thorough laboratory tests, first batch is released to the National Institutes of Health (NIH) for phase-1 clinical study
- NIH files application for phase-1 clinical trials to US Food and Drug Administration (FDA)
March
- A major milestone, FDA gives green signal to the NIH application
- NIH gets its first participant for phase-1 study
- By now, 63 days have elapsed from sequence selection
- Phase-1 study was crucial as it was about to provide important data on the safety and immunogenicity of mRNA-1273
- It is difficult to make vaccine commercially for at least 12-18 months
- Under emergency and proper authorization, a vaccine could be available to some people like healthcare professionals
- Moderna confirms scaling up capacity to produce millions of doses per month
- NIH decides on open-label trial for 45 healthy adult volunteers aged between 18 to 55 years for over six weeks
- Emory University in Atlanta is identified to carry out phase-1 trials
April
- US government funds Moderna to accelerate development, licensing and large-scale production of mRNA-1273
- On April 27th, Moderna files application for phase-2 study
May
- Moderna and Lonza, a Swiss biotechnology company, announce a worldwide collaboration
- The goal is to manufacture mRNA-1273 up to 1 billion doses per year.
- Moderna gets approval to proceed with Phase-2 study
- Phase-3 trial is on the cards
Appendix – Some nice things to learn
- Open-label trial means no information will be with held from the participants.
- Immunogenicity means the ability of the vaccine to induce an immune response in participants.
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